Zonisamide for Alcoholism
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Washington State University
Must not be taking: Alcohol medications
Disqualifiers: Severe substance use, Seizure disorder, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?A phase II randomized, double-blind, placebo-controlled clinical trial (RCT) to evaluate the ability of zonisamide (ZON) to decrease alcohol use among treatment-seeking adults with an alcohol use disorder (AUD).
Will I have to stop taking my current medications?
The trial requires that you are not currently receiving any medication for alcohol use or have taken such medication in the past 30 days. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Zonisamide for treating alcoholism?
Research shows that Zonisamide, an anticonvulsant drug, has been effective in reducing alcohol intake in both animal studies and human trials, indicating its potential to help treat alcohol dependence.
12345Is zonisamide safe for humans?
Zonisamide has been used in over 2 million patient-years for epilepsy and is generally well-tolerated, with most side effects being mild to moderate. In studies for alcohol dependence, it was evaluated for safety and tolerability, and serious side effects were rare, similar to placebo.
13467How does the drug zonisamide differ from other treatments for alcoholism?
Zonisamide is unique because it is an anticonvulsant drug that affects multiple brain systems, including GABAergic, glutamatergic, and monoaminergic pathways, which may help reduce alcohol intake. Unlike traditional treatments for alcoholism, zonisamide is primarily used for epilepsy and has shown potential in reducing alcohol consumption in both animal studies and early human trials.
13478Eligibility Criteria
The ZARRA Study is for adults aged 18-65 with an alcohol use disorder who drink heavily and are seeking treatment. They must be able to read and speak English, consent to the study, have a negative breath alcohol test, provide positive urine tests for alcohol use, and if female and of childbearing age, not be lactating and using birth control. People with severe allergies or recent detox history, other severe substance disorders (except nicotine), significant health issues or taking certain medications can't join.Inclusion Criteria
Ability to read and speak English
Breath alcohol of 0.00 during informed consent
Seeking AUD treatment
+7 more
Exclusion Criteria
Systemic autoimmune disease
I do not have any serious health issues that could make the study risky for me.
Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive zonisamide or placebo plus standard treatment for alcohol use disorder
12 weeks
1 visit weekly (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 year
Visits at weeks 18, 38, and 54 (in-person or virtual)
Participant Groups
This phase II trial is testing whether zonisamide (ZON) helps reduce alcohol consumption in people wanting to treat their heavy drinking habits. Participants will randomly receive either ZON or a placebo without knowing which one they're getting. The goal is to see if there's a difference in how much they drink while on these treatments.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZON+STExperimental Treatment1 Intervention
Zonisamide (ZON) plus standard treatment (ST)
Group II: PLO+STPlacebo Group1 Intervention
Placebo (PLO) plus standard treatment (ST)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington State UniversitySpokane, WA
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Who Is Running the Clinical Trial?
Washington State UniversityLead Sponsor
References
A pharmaco-EEG-based assessment of the interaction between ethanol and zonisamide. [2018]Recent research suggests a potential role for a new generation of anticonvulsant drugs, including zonisamide, in the treatment of alcohol dependence. Some elements of the central mechanism of action that zonisamide has in common with ethanol, give rise to the question of whether there is an interaction between these two agents and whether there is any risk associated with the enhanced depressive effect of these agents on the central nervous system.
Status of disulfiram in present day alcoholic deaddiction therapy. [2021]Assessment of safety and efficacy profile of disulfiram (DSM) in the alcoholic de-addiction regimen.
Placebo-controlled trial of zonisamide for the treatment of alcohol dependence. [2021]Zonisamide is an anticonvulsant medication with GABAergic, glutamatergic, and monoaminergic effects. Zonisamide has also been shown to reduce alcohol intake in rodents and in risky drinkers in the context of a laboratory study. This pilot clinical trial evaluated the safety, tolerability, and efficacy of zonisamide for the treatment of alcohol dependence.
Open label trial of the tolerability and efficacy of zonisamide in the treatment of alcohol dependence. [2021]The objectives of this study are to assess the tolerability and efficacy of the anticonvulsant zonisamide in an open label trial of the treatment of alcohol dependence.
[Amisulpride for the treatment of alcohol dependence]. [2018]6-month naturalistic, open-label trial to compare amisulpride versus topiramate and naltrexone as a treatment for patients with alcohol dependence, with assessments at enrolment and after 3 and 6 months of treatment.
Retention rate of zonisamide in intractable epilepsy. [2018]To assess the effect and tolerability of zonisamide (ZNS) as adjunctive treatment for difficult-to-treat epilepsy in adult Scandinavian patients.
Zonisamide as adjunctive therapy for refractory partial seizures. [2018]Zonisamide (Zonegran) has been used extensively worldwide (>2 million patient-years experience) for the effective treatment of a broad range of epilepsy indications. Four randomised, placebo-controlled trials (duration or=300 mg/day to be efficacious in treating refractory partial seizures in adults. In a pivotal European study, zonisamide 500 mg/day was significantly superior to placebo in reducing the frequency of complex partial seizures (-51% versus -16%), all partial seizures and all seizures, with dose-dependent benefit provided over a 100-500 mg/day dose range. Supporting trials have confirmed significant increases in reduction in median seizure frequency (up to 41%) and responder rates (35-42%) compared with placebo following zonisamide 400-600 mg/day, enabling 20-27% of patients to attain >or=75% reduction in seizure frequency. Pooled data from all four placebo-controlled trials demonstrate an excellent tolerability and safety profile; adverse events are generally of mild-moderate severity with few leading to discontinuation, and incidence of serious adverse events is comparable to placebo. These data support the use of zonisamide in combination with commonly used antiepileptic drugs to provide efficacious and well-tolerated treatment for patients with refractory partial seizures.
Zonisamide: newer antiepileptic agent with multiple mechanisms of action. [2019]Zonisamide (Zonegran, Eisai, Inc.) is a broad spectrum antiepileptic drug indicated for use as adjunctive therapy in the treatment of partial seizures. Zonisamide has multiple mechanisms of action, which may explain widespread reports of its utility in focal epilepsy and generalized epilepsy, and for nonseizure disorders such as headache and neuropathic pain. Zonisamide has been available in Japan since 1989 and became available in the USA in 2002. The rights to this drug in North America and Europe were recently acquired by Eisai Co. A review of the chemical properties, pharmacokinetics, metabolism, potential mechanisms of action, efficacy in seizure and nonseizure disorders, and tolerability was therefore thought to be timely.